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Patient-Derived Organoids for Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04371198
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : January 13, 2021
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to determine the feasibility of establishing patient-derived organoids from pre-treatment rectal adenocarcinoma biopsies.

Condition or disease Intervention/treatment Phase
Rectum Cancer Other: Biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility of Establishing Patient-Derived Organoids for Rectal Cancer: A Biospecimen Collection Protocol
Actual Study Start Date : July 28, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Organoid Other: Biopsy
Tissue biopsy

Primary Outcome Measures :
  1. fraction of biopsies that form spherical organoids. [ Time Frame: baseline ]
    number of biopsies that form successfully form spherical organoids divided by the total number of tumor biopsies collected

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  1. Age ≥18 years old.
  2. Able to provide informed consent.
  3. Undergoing proctoscopy.


1. Patient not planned to receive neoadjuvant radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04371198

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Contact: Heather Franklin (919) 668-3726

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United States, North Carolina
Duke Cancer Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Heather Franklin, RN BSN    919-668-3726   
Principal Investigator: Brian Czito, MD         
Sponsors and Collaborators
Duke University
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Principal Investigator: Brian Czito, MD Duke University Health System
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Responsible Party: Duke University Identifier: NCT04371198    
Other Study ID Numbers: Pro00104561
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data and organoids may be shared with other researchers
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 6 months after publication
Access Criteria: Researchers should request data and/or organoid lines from the principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases